Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-14 @ 11:45 PM
Study NCT ID:
NCT05330312
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2022-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@vicorepharma.com', 'phone': '+46317880560', 'title': 'Director Clinical Operations', 'organization': 'Vicore Pharma'}, 'certainAgreement': {'otherDetails': 'The primary publication should be published by the sponsor prior to any other investigator-initiated publications, manuscripts, abstracts, or presentations.\n\nThe results of this clinical investigation may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.', 'description': 'In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 2 - Digital Cognitive Behavioral Therapy', 'description': '9 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 3, 'seriousNumAtRisk': 53, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Part 2 - Control Group', 'description': 'No intervention', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 4, 'seriousNumAtRisk': 54, 'deathsNumAffected': 4, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Part 1 - Digital Cognitive Behavioral Therapy', 'description': '4 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}], 'seriousEvents': [{'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.', 'description': 'Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.'}], 'classes': [{'title': 'The device was intuitive and easy to use', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Feature allowing users to review entries in the tool to be added to the device', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Account setting page for users to be added to the device (e.g. for resetting password)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Difficulties in following the audio tool guidance', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Notifications for daily prompts for device usage to be added', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Qualitative information on functionality and experience was collected from 10 participants.'}, {'type': 'PRIMARY', 'title': 'Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Cognitive Behavioral Therapy', 'description': 'Part 2: 9 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '2.4'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '5.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 7 questions. Each question will be scored on a 4-point scale from 0 to 3 points. Higher score will mean a worse outcome.\n\nThe GAD-7 represents an anxiety measure based on seven items which are scored from zero to three (0=Not at all,1=Several days, 2=More than half the days and 3=Nearly every day). The composite score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 1 - Safety of dCBT-PF-in Patients With IPF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Cognitive Behavioral Therapy', 'description': '4 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 4', 'description': 'Information on AEs, ADEs, SAEs, SADE and device deficiencies which could lead to an ADE or SADE was collected at visits at week 2 and week 4.', 'unitOfMeasure': 'Adverse event', 'reportingStatus': 'POSTED', 'populationDescription': '1 AE was reported in the pilot phase of the investigation. AE information was not collected for the subject who did not initiate treatment.'}, {'type': 'SECONDARY', 'title': 'Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Cognitive Behavioral Therapy', 'description': 'Part 2: 9 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-8.7', 'upperLimit': '-4.7'}, {'value': '-4.7', 'groupId': 'OG001', 'lowerLimit': '-6.5', 'upperLimit': '-2.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 14 questions rating the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) will be summed up to give a total possible score of 0 to 56, where lower scores indicate less anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Cognitive Behavioral Therapy', 'description': 'Part 2: 9 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '11.9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '5.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Cognitive Behavioral Therapy', 'description': 'Part 2: 9 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '7.3'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '2.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 2 - Digital Cognitive Behavioral Therapy', 'description': '9 weeks of digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'FG001', 'title': 'Part 2 - Control Group', 'description': 'No intervention'}, {'id': 'FG002', 'title': 'Part 1 - Digital Cognitive Behavioral Therapy', 'description': '4 weeks of digital cognitive behavioral therapy\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}], 'periods': [{'title': 'Pilot Investigation - Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'In the pilot phase subjects received 4 weeks digital cognitive behavioral therapy.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'There was no control group in the Pilot phase', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Pivotal Investigation - Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'comment': 'Subject from the Part 1 (pilot phase) did not take part in Part 2.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '11 subjects were enrolled in the pilot phase (Part 1) to receive 4 weeks of dCBT.\n\n108 subjects were enrolled in the pivotal phase (Part 2) to recieve either 9 weeks of dCBT or no intervention.', 'preAssignmentDetails': 'This investigation consisted of two parts:\n\nPart 1 - A pilot phase with the key purpose of testing the functionality of dCBT-PF.\n\nPart 2 - A pivotal phase with the key purpose of evaluating the efficacy of dCBT-PF versus a control on patient-reported psychological symptom burden in patients with PF.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 2 - Digital Cognitive Behavioral Therapy', 'description': 'Part 2: 9 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'BG001', 'title': 'Part 2 - Control Group', 'description': 'No intervention'}, {'id': 'BG002', 'title': 'Part 1 - Digital Cognitive Behavioral Therapy', 'description': 'Part 1: 4 weeks digital cognitive behavioral therapy.\n\nDigital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '10.21', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '8.12', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '9.38', 'groupId': 'BG002'}, {'value': '67.5', 'spread': '9.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One subject randomised to dCBT-PF in Part 2 was not treated, as the subject was unable to download the app.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-27', 'size': 2478074, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-04T10:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'HAM-A raters are blinded (HAM-A = Hamilton Anxiety Rating Scale).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigation consisted of a Part 1 (pilot phase) with a single arm (4 weeks of dCBT), and a Part 2 (pivotal phase) with a randomised, controlled, parallel-group design to either 9 weeks of dCBT or a control group with no intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2022-03-03', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide.'}, {'measure': 'Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.', 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 7 questions. Each question will be scored on a 4-point scale from 0 to 3 points. Higher score will mean a worse outcome.\n\nThe GAD-7 represents an anxiety measure based on seven items which are scored from zero to three (0=Not at all,1=Several days, 2=More than half the days and 3=Nearly every day). The composite score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.'}], 'secondaryOutcomes': [{'measure': 'Part 1 - Safety of dCBT-PF-in Patients With IPF', 'timeFrame': 'Baseline to week 4', 'description': 'Information on AEs, ADEs, SAEs, SADE and device deficiencies which could lead to an ADE or SADE was collected at visits at week 2 and week 4.'}, {'measure': 'Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9', 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 14 questions rating the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) will be summed up to give a total possible score of 0 to 56, where lower scores indicate less anxiety.'}, {'measure': "Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9.", 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.'}, {'measure': "Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9.", 'timeFrame': 'Baseline to Week 9', 'description': 'The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.', 'detailedDescription': 'Patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Patients will be treated for 9 weeks, followed by a 3 week follow-up period. Efficacy will be assessed after 9 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥22 years at the time of signing the informed consent\n2. Self-reported Pulmonary Fibrosis diagnosis\n3. A GAD-7 score of ≥5 at pre-screening and baseline\n4. If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to baseline\n5. CT scan report within 5 years prior to baseline with signs of PF (interstitial changes)\n6. Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device\n\nExclusion Criteria:\n\n1. Self-reported manic disorders, psychotic disorders, schizophrenia, or alcohol/drug abuse during the past 6 months prior to baseline (Visit 1), as judged by the investigator or designee.\n2. Self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee\n3. Self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee\n4. Verbal and/or written communication problems limiting ability to engage with dCBT-IPF\n5. Inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee\n6. Currently receiving cognitive behavioral therapy'}, 'identificationModule': {'nctId': 'NCT05330312', 'acronym': 'COMPANION', 'briefTitle': 'Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vicore Pharma AB'}, 'officialTitle': 'A Randomized, Controlled, Parallel-group Clinical Investigation Evaluating the Impact of Digital Cognitive Behavioural Therapy on Psychological Symptom Burden in Adults Diagnosed With Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'VP-dCBT-PF-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 - Digital cognitive behavioral therapy', 'description': '4 weeks digital cognitive behavioral therapy.', 'interventionNames': ['Device: Digital cognitive behavioral therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Part 2 - Control group', 'description': 'No intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - Digital cognitive behavioral therapy', 'description': '9 weeks digital cognitive behavioral therapy', 'interventionNames': ['Device: Digital cognitive behavioral therapy']}], 'interventions': [{'name': 'Digital cognitive behavioral therapy', 'type': 'DEVICE', 'otherNames': ['dCBT-PF'], 'description': 'Therapy for patients with pulmonary fibrosis', 'armGroupLabels': ['Part 1 - Digital cognitive behavioral therapy', 'Part 2 - Digital cognitive behavioral therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Curebase Study Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '84025', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Maureen Horton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Curebase study site'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vicore Pharma AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Curebase Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}